Calibration and Qualification of Stability Chambers

This seminar will discuss how to calibrate and qualiy stability chambers for FDA and international compliance.
Sept. 16, 2012 - PRLog -- Why to attend:
Well performing stability chambers are most important to reliably predict shelf life specifications of drugs at different environmental conditions on the way from manufacturing to patients. FDA and international agencies expect  stability chambers to be qualified and calibrated to ensure proper performance when newly installed and over the length of a stability study. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis. During the seminar, the speaker will present cost-effective calibration and qualification strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help trouble-free implementation.

Areas Covered in the Seminar:

* FDA and equivalent international requirements
* Examples for recent 483s and Warning Letters
* Selection and qualification model: ASTM E2500, USP 1058, V- or, 4-Q models
* Calibration/qualification phases: design qualification, specifications, installation & operational qualification/verification testing, on-going performance qualification
* Selecting parameters and acceptance limits for stability chambers testing
* Qualification for Photostability Testing Chambers
* Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade)
* Documentation requirements, e.g., humidity and temperature mapping
* Common pitfalls
* Sharing best practices
* Going through Most frequently asked questions

And for easy and instant implementation:
download 10+ documents from special seminar website.
They include

* SOP: Qualification and Calibration of Stability Chambers
* SOP: Testing of Stability Chambers
* SOP: Change Control for Equipment
* SOP: Maintenance of Equipment
* SOP: Development and Maintenance of Test Scripts
* Example: Qualification Plan
* Example: Requirement Specifications
* Example: Risk Assessment
* Example: Vendor Assessment
* Example: Design Qualification
* Example: Installation Qualification
* Example: Operational Qualification
* Example: Performance Qualification
* Example: Test Sheet
* Example: Summary Report
* Examples for FDA Warning Letters Related to Stability Chamber Qualification.

Date:  October 11,2012
Time: 11.00 - 12.00 a.m. ET
Location: Online, worldwide

Who should attend
* Managers and staff of stability testing laboratories
* Analysts and lab managers
* Validation specialists
* QA managers and personnel
* Regulatory affairs
* Training department
* Documentation department
* Consultants


Presenter: Dr. Ludwig Huber

Category: Pharmaceutical, API Manufactuer, FDA, Training, Stabilty testing, Laboratories

Ludwig Huber, Ph.D., is Director for global FDA compliance at Labcompliance. He is the author and editor of, the global on-line resource for validation and laboratory compliance. Dr. Huber has been presenting more than 200 web, video and audio seminars. He has been selected as IVT's "Presenter of Year" out of 175 presenters. He is also the author of more than 100 papers including the bestselling books “Validation of Computerized Analytical Systems” and “Validation and Qualification in Analytical Laboratories,”. Currently, Dr. Huber is on the Scientific Advisory board of IVT’s GxP and Validation Journals, and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars and presentations for the  US FDA, ISPE, PDA, PIC/S and several national health agencies including China SFDA
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Tags:Stability Testing, Chambers, Calibration, Qualification
Industry:Pharmaceutical, API-Manufacturer
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